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Home » Authors » Shani Alexander

Articles by Shani Alexander

Smart Reporting software

Smart Reporting raises €23M for medical software

April 22, 2024
By Shani Alexander
Smart Reporting GmbH raised €23 million (US$24.5 million) in a series C funding round for its medical reporting software which automates and streamlines physicians’ workload. The funding is a “significant accelerator” for the company, “catalyzing business growth, product development, and expansion into international markets,” Wieland Sommer, founder and co-CEO of Smart Reporting told BioWorld.
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British flag

UK taking steps to boost adoption of med tech at the NHS

April 19, 2024
By Shani Alexander
The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives.
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Bone marrow illustration with doctor background

Scopio wins FDA clearance for bone marrow aspirate application

April 18, 2024
By Shani Alexander
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.
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Ingenion Medical Cymactive 2

Ingenion receives CE mark for Cymactive urinary catheter

April 17, 2024
By Shani Alexander
Ingenion Medical Ltd. received a CE mark for its Cymactive 2.0R urinary catheter, a device to treat men suffering from chronic, non-neurogenic urinary retention. The technology, designed to mimic natural urination, will “transform” the lives of men currently struggling with the challenges of using Foley-type catheters, Edward Cappabianca, CEO of Ingenion Medical told BioWorld.
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Illustration of cryoblation procedure in breast

Icecure seeks FDA authorization to market cryoablation system for breast cancer

April 16, 2024
By Shani Alexander
Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Roche, Eli Lilly Alzheimer's blood test granted breakthrough device designation

April 15, 2024
By Shani Alexander
The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.
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Endostart Endorail system

Endostart granted FDA clearance for Endorail colonoscopy device

March 28, 2024
By Shani Alexander
Endostart s.r.l. received U.S. FDA 510(k) clearance for Endorail, a magnetic balloon system which helps resolve intestinal looping and facilitates the efficiency and safety of colonoscopy procedures. The approval is an “important milestone” for the company as it will allow Endostart to bring its technology to the U.S. market to empower physicians, Alessandro Tozzi, co-founder and CEO of the company, told BioWorld.
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CINA ASPECTS

FDA clears Avicenna.AI tools focused on pulmonary embolism, stroke

March 27, 2024
By Shani Alexander
Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.
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Metyos biowearable sensor

Metyos raises €2.3M for patch which monitors chronic kidney disease

March 26, 2024
By Shani Alexander
Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.
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Ultrahuman Ring

Ultrahuman raises $35M to accelerate growth

March 25, 2024
By Shani Alexander
Ultrahuman Healthcare Private Ltd. recently raised $35 million in a series B investment round to accelerate the company’s growth. Ultrahuman has developed several products, most notably a smart ring, which measures a range of physiological signals to impact health and wellbeing.
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